Bioanalytical Lab Manager
Company: Arrowhead Pharmaceuticals
Location: Madison
Posted on: March 19, 2023
Job Description:
The PositionInitially, the Lab Manager will assist in the set up
and implementation of a GLP lab. Once the GLP lab is established,
the Lab Manager will lead a team of scientists in regulated method
validation and sample analysis in support of GLP toxicokinetic and
GCP pharmacokinetic studies. The lab manager will have expertise
with LC-MS and HPLC-FL analytical platforms and is well versed in
regulated bioanalysis. The lab manager will establish and lead
bioanalytical training and provide expertise to less experienced
scientists. The lab manager will be joining a team of highly
motivated and experienced scientists and will contribute to the
success of Arrowhead development programs. - -Responsibilities
Assist with the set up and
implementation of a GLP lab to support regulated method validations
and sample analysis, including LIMS setup, IQ/OQ/PQs and
calibrationsHelp set up/review SOPs and templates related to GLP
bioanalysisBuild and lead a team to support internal regulated
bioanalysisLead and mentor a team of bioanalytical scientists,
providing technical and career development guidance, including
managerial duties such as performance goals, reviews and talent
developmentDevelop a training program and lead training of junior
scientistsEnsure work is compliant per GLP/GCP regulatory
requirements and stay up-to-date on relevant regulationsLead method
validations of bioanalytical assays via HPLC-FL and LC-MS/MS,
evaluate assay and instrument performance, ability to troubleshoot
issuesLead lab organization and maintain instrumentationConduct
peer review of data, protocols and reportsEffectively manage
workload and monitor and evaluate team completion of tasks and
projectsWorks collaboratively with cross-functional teams (PM,
Clinical, DMPK, QA, QC, Regulatory and others as needed) to develop
and meet project goals, deliverables, and timelinesTrack progress
against project -timelines, generate regular status updates, and
communicate progress and issues to management and cross-functional
teamsMulti-task across several projects and manage time effectively
to achieve resultsAdhere to safe laboratory practicesRequirements:
- Minimum BS degree with 10+ years or MS with 7+ years or PhD
with 5+ years of relevant experience in the pharmaceutical/CRO
industry
- Demonstrated method development experience with various
analytical platforms and deep expertise with LC-MS and LC-FL
- Demonstrated project and time management
- Experience leading and training other scientists and leading
lab organization and processes -
- Good documentation practices with excellent organization and
attention to detail
- Demonstrated innovation, creativity and resilience in problem
solving
- Excellent oral and written communication skills
- Self-motivated team player with the ability to thrive in a fast
paced, dynamic, multi-disciplinary, matrixed environment -Powered
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Keywords: Arrowhead Pharmaceuticals, Madison , Bioanalytical Lab Manager, Healthcare , Madison, Wisconsin
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